Category: Regulations

Our Government Sends 19-Year-Olds to War but Does Not Allow Them to Try High-Risk, High-Reward Covid-19 Drugs and Vaccines

(p. A11) “Many drug programs are suspended or not pursued at all—not because of flaws in the science but because of commercial and strategic reasons,” Mr. Milken says. Researchers screen those programs, and he calls in his partners either to fund the ideas or promote their development at other companies if the inventors make them available.

It’s a niche in the pharmaceutical world that public funding can’t fill. Mr. Milken sustains a model “where a person could just give me a five-page summary and get a meeting. Government isn’t going to fund that, but philanthropy does.” “These little companies,” he adds—“they’re not Johnson & Johnson, they’re not Novartis, they’re not Amgen. They need financial capital.”

. . .

Mr. Milken’s deals not tinged by controversy, such as his 1983 issuance of bonds to finance telecom company MCI’s long-distance network, show the same preference that shapes his philanthropy: high risk for a high reward.

. . .

A perennial struggle for Mr. Milken has been to convince regulators to share that urgency. He says drug trials generally are too rigid: “We send 19-year-olds into war zones knowing that no matter what we do, some number—greater than zero—will lose their lives or their limbs. But we tell a patient who is going to die not to try something because it could be dangerous.”

Nonetheless, the partners he’s made in his search for cures prove that imagination and activity are still scattered through the country. Discussing the coronavirus with biotech founders and Nobel Prize winners, Mr. Milken says he’s been “thrust back into the 1970s and early ’80s, where any time someone had a new idea—a new company, a passion for something—I had set aside time every day to listen.” On the day a vaccine or effective cure for Covid-19 is finally announced, Americans will owe thanks to such risk takers, who Mr. Milken says “invest in where the world is going, not where it is.”

For the full interview, see:

Mene Ukueberuwa, interviewer. “THE WEEKEND INTERVIEW; What Would You Risk for a Faster Cure?” The Wall Street Journal (Saturday, May 2, 2020): A11.

(Note: ellipses added.)

(Note: the online version of the interview has the date May 1, 2020, and has the same title as the print version.)

Former FDA Research Virologist Suggests “Accelerated Approvals” of Covid-19 Vaccines

(p. A15) Covid-19 is a genuine emergency. Drug and biotech companies and academic institutions are doing their part, and regulators need to, as well. Having been a research virologist who spent 15 years at the FDA as the agency’s “biotechnology czar,” I have some suggestions:

. . .

• The FDA should issue “accelerated approvals” after testing in only limited populations. Additional subgroups—children, pregnant women, etc.—can be tested after approval. The accelerated approvals should be granted before the duration of postvaccination immunity has been ascertained. More-comprehensive trials can then confirm safety, efficacy and the length of time that immunity lasts.

• Establish reciprocity of approvals between the FDA and trusted counterparts in certain foreign countries (Australia, Canada, New Zealand, Japan, the Scandinavian countries and the European Medicines Agency), so that if one of them approves a vaccine, it is automatically approved in the other countries.

For the full commentary, see:

Henry I. Miller. “A Covid Vaccine: Faster, Please.” The Wall Street Journal (Thursday, April 23, 2020): A15.

(Note: ellipsis added.)

(Note: the online version of the commentary has the date April 22, 2020, and has the title “A Coronavirus Vaccine: Faster, Please.”)

Patients Die Due to Doctors Who Are “Busy Entering Health Care Data” Required by “Mandated Protocols”

(p. 18) Doctors today often complain of working in an occupational black hole in which patient encounters are compressed into smaller and smaller space and time. You can do a passable job in a 10-minute visit, they say, but it is impossible to appreciate the subtleties of patient care when you are rushing.

Enter “Slow Medicine: The Way to Healing,” a wonderful new memoir by Dr. Victoria Sweet.

. . .

One of the most compelling stories in the book is about Joey, a 3-year-old who is diagnosed with terminal lung disease after a near-drowning but against the odds makes it off the ventilator and out of the hospital. Sweet interprets Joey’s recovery in part as a victory for prayer. “Prayer worked,” she writes, “at least that once and maybe sometimes and maybe always.” I would see it differently: Joey was saved because a lung specialist slowly decreased airway pressure and tidal volume over several weeks in a patient with acute respiratory distress syndrome. And, as Sweet points out, it was slow medicine that allowed that doctor to make the proper adjustments.

Perhaps Sweet’s most depressing conclusion is that Joey would have died today. His doctors “would have been too busy entering health care data” that was required “according to all the mandated protocols.”

For the full review, see:

Sandeep Jauhar. “Heals Over Time.” The New York Times Book Review (Sunday, January 28, 2018): 18.

(Note: ellipsis added.)

(Note: the online version of the review has the date Jan. 26, 2018, and has the title “A Doctor Argues That Her Profession Needs to Slow Down, Stat.”)

The book under review is:

Sweet, Victoria. Slow Medicine: The Way to Healing. New York: Riverhead Books, 2017.

Fauci Criticizes Russia for Allowing Citizens to Take Covid-19 Vaccine After Passing Phase 2 Safety Trials

Milton Friedman thought that, at the very least, the FDA should allow Americans the freedom to choose to take drugs or vaccines after their safety has been established (basically meaning after passing the Phase 2 safety trials). Isn’t it strange that in the FDA’s United States, citizens may not do so, but in Putin’s authoritarian Russia, citizens are allowed that choice?

(p. A4) In a panel discussion, Dr. Anthony S. Fauci, the nation’s top infections disease expert, criticized Russia’s rushed clearance of a coronavirus vaccine. The vaccine, called Sputnik V, was approved without evidence that Phase 3 clinical trials had been completed, an essential part of the development pipeline to prove a product is safe and effective in people.

. . .

Dr. Fauci called attention to the many other coronavirus vaccines vying for eventual clearance, including several that are in Phase 3 trials in the United States. The process for testing vaccines can last months and usually involves thousands of people.

“So if we wanted to take the chance of hurting a lot of people or giving them something that doesn’t work, we could start doing this, you know, next week if we wanted to,” Dr. Fauci said. “But that’s not the way this works.”

For the full story, see:

Barron, James. “Coronavirus Update.” The New York Times (Thursday, August 11, 2020): A4.

(Note: ellipsis added.)

(Note: the online version of the story was updated August 14, 2020, and has the title “U.S. Coronavirus Death Toll Reflects Sun Belt Outbreaks.” Where there are slight differences in wording between the versions in the passages quoted, the online version appears above. The online version does not list an author. I cite James Barron, who is listed as the author in the print version.)

Viruses Mutate More Nimbly Than Therapies Hobbled by FDA Regulations

(p. A7) In a laboratory in New York City, researchers coaxed a key piece of the coronavirus — its infamous outer “spike” — to mutate so that it became invisible to disease-fighting antibodies, according to a new study that has not yet been published in a scientific journal.

The provocative finding should not set off alarm bells, experts said. The altered spikes were not attached to the real coronavirus, which mutates at a much slower pace than most laboratory viruses. But the study does underscore the need for treatments and vaccines that attack the virus in different ways, so that if the pathogen manages to evade one approach, another will be waiting in the wings.

“It’s an old story for virology,” said Dr. Sallie Permar, a virologist and pediatrician at Duke University who was not involved in the study. “If you only target one little region, that virus is going to find a way to get away from it. It’s why viruses are so successful in this world.”

. . .

Several types of monoclonal antibodies are now in clinical trials. If all goes well, such concoctions might not only treat coronavirus infections but also prevent them. That could help millions of people, especially as the world awaits a vaccine, said Akiko Iwasaki, an immunologist at Yale University who was not involved in the study.

But the new findings also hint that single-antibody formulations “may not be as successful,” Dr. Taylor said, at least in the long term. Developing a cocktail containing a diverse blend of antibodies could be a safer bet.

Such mixtures would also more accurately mimic the body’s natural response to the coronavirus. In the study, viruses flushed with samples of convalescent plasma — fractions of blood donated by people who have recovered from Covid-19 — struggled to infect cells.

Some scientists, including those at American biotechnology company Regeneron, are already attempting this combo approach, mixing two potent types of monoclonal antibodies into a single treatment.

But Dr. Iwasaki pointed out that antibody cocktails might be tougher to bring to market. “Every time you make a drug, you get approval for each component separately,” she said. . . .

The lesson of diversity might be even more powerful for vaccines, which can marshal a multifaceted immune response. Some immune cells and molecules will be tailored to home in on the spike, whereas others might prefer other parts of the virus. Vaccines that present the body with many pieces of the coronavirus, rather than the spike alone, could have a better shot at triggering a suite of these defenses, said Dr. Taia Wang, an immunologist at Stanford University who was not involved in the study.

For the full story, see:

Katherine J. Wu. “Experiment on Spike Protein Shows Obstacles of Mutation.” The New York Times (Wednesday, July 29, 2020): A7.

(Note: ellipsis added.)

(Note: the online version of the story has the date July 28, 2020, and has the title “The Coronavirus Could Dodge Some Treatments, Study Suggests.” The online version has an extra paragraph that does not appear in the print version. In my quotations above, I stick to the print version.)

Masks “Absolutely Essential” to “Get Control of the Virus”

(p. 6A) Adm. Brett Giroir, a member of the White House coronavirus task force, called mask-wearing in public, which has been met with resistance in some U.S. states, “absolutely essential.”

Giroir, the assistant secretary at the Health and Human Services Department, told ABC’s “This Week” on Sunday [July 12, 2020] that “if we don’t have that, we will not get control of the virus.”

For the full story, see:

AP. “As U.S Wrestles With Virus Florida Sets Daily Record.” Omaha World Herald (Monday, July 13, 2020): A6.

(Note: bracketed date added.)

Jim Pethokoukis Asks Art Diamond How to Increase Innovative Dynamism

Jim Pethokoukis recently posted an abbreviated transcript of our conversation on his Political Economy podcast about my Openness to Creative Destruction: Sustaining Innovative Dynamism book.

Posted by Arthur Diamond on Thursday, August 6, 2020

China Allows Some Volunteers to Receive Covid-19 Vaccines After Only Phase 2 Trials

(p. B1) The offer to employees at the state-owned oil giant was compelling: Be among the first in China to take a coronavirus vaccine.

The employees at PetroChina could use one of two vaccines “for emergency use” to protect themselves when working overseas as part of China’s ambitious infrastructure program, according to a copy of the notice, which was reviewed by The New York Times.

. . .

(p. B6) Such “emergency use” is rare, and the taking of unapproved vaccines is typically reserved for health care professionals. Although the government has stressed that taking the vaccine is voluntary, the state-owned workers and soldiers could feel pressure to participate.

. . .

Along with the testing at the oil company, Sinopharm, which has completed Phase 2 trials for two products, has injected the vaccine into its chairman and other senior officials, according to the State-owned Assets Supervision and Administration Commission, or SASAC, the government agency managing all employees at state-backed companies. The Chinese government has allowed the CanSino-military vaccine to be given to its armed forces, a first for the military of any country.

. . .

“If you are a regulatory body, if you play by the rules, if you are hard-nosed about it, you say this is very wrong,” said Ray Yip, the former head of the Gates Foundation in China.

Dr. Yip added that it would be useful for company executives to know that they had given the dose to “a couple of thousand people, but no one has dropped dead, so that’s pretty good.”

Dr. Yip said the people taking the vaccines should read up on reports of the safety data and make an informed decision. He said he would be willing to take it.

“If you offer that to me saying it’s safe and there’s an 85 percent chance that it works, would I take it today?” he said. “You know what, I probably will. Because then I don’t have to worry.”

In a post on its official WeChat account, a government agency reported that the “vaccine pretest” on Sinopharm employees showed that antibody levels were high enough in subjects to combat the coronavirus, indicating that it was safe and effective.

. . .

In June [2020], Sinopharm began the third phase of clinical trials in Beijing, Wuhan and Abu Dhabi, becoming the first company to enter the final regulatory stage. China’s Sinovac Biotech is teaming up with Instituto Butantan in Brazil, which has the world’s second-highest case count after the United States.

. . .

Dimas Tadeu Covas, the director of Butantan, said that he was impressed with Sinovac’s preliminary results and that the vaccine “has the greatest potential for success.” He cited results from Sinovac’s Phase 1 trials that showed no adverse effects and Phase 2 trials that showed 90 percent protection against Sars-Cov2.

“I know vaccines, and I am betting a lot on this one,” Dr. Covas said.

For the full story, see:

Sui-Lee Wee and Mariana Simões. “China Skirts Convention For Vaccines.” The New York Times (Friday, July 17, 2020): B1 & B6.

(Note: ellipses added.)

(Note: the online version of the story was updated June 17, 2020, and has the title “In Coronavirus Vaccine Race, China Strays From the Official Paths.”)

“Quite Good” Moderna Vaccine Starts Phase 3 Trial on July 27, 2020

(p. A6) New details about the first human study of Moderna Inc.’s experimental coronavirus vaccine emerged Tuesday, which researchers said reinforced their decision to take the shot into a large, decisive clinical trial scheduled to start in late July [2020].

The new results, published online by the New England Journal of Medicine, showed that the vaccine induced the desired immune response for all 45 people evaluated—a larger group than in the preliminary data Moderna released in May—and was generally safe and well-tolerated.

“This is really quite good news,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in an interview Tuesday. NIAID co-developed the Moderna vaccine and led the study.

“The gold standard of protection against a viral infection is neutralizing antibodies,” he added. “And the data from the study, small numbers as it may be, are pretty clear that this vaccine is capable of inducing quite good [levels] of neutralizing antibodies.”

Researchers said they found no serious safety risks, though some participants had injection-site pain and symptoms such as fatigue, headache and chills.

Dr. Fauci said it is possible that the coming large study would yield an answer by year-end about whether the vaccine induced immune responses sufficient to protect people safely from Covid-19. A positive answer would clear the way for wider use and potentially help curb the deadly pandemic.

The new “Cove” study, scheduled to start July 27, will aim to enroll about 30,000 adults at nearly 90 different U.S. locations.

For the full story, see:

Loftus, Peter. “Data Show Vaccine Is Ready for Big Trial.” The Wall Street Journal (Weds., July 15, 2020): A6.

(Note: bracketed year added.)

(Note: the online version of the story was updated June 14, 2020, and has the title “Moderna’s Covid-19 Vaccine Moves to Bigger Study.”)